The HPRA advises healthcare professionals not to retain printed versions of Summary of Product Characteristics (SPC) documents. As these documents are subject to frequent content updates, including changes to safety and dose related information, we recommend that you visit our website as necessary to access the most up-to-date versions. If you have any queries about specific SPCs on our website then please e-mail

ReFacto AF

1000 international unit(s) Powder and solvent for solution for injection

Pfizer Europe MA EEIGEU/1/99/103/007

Main Information

Trade NameReFacto AF
Active SubstancesMoroctocog alfa
Strength1000 international unit(s)
Dosage FormPowder and solvent for solution for injection
Licence HolderPfizer Europe MA EEIG
Licence NumberEU/1/99/103/007

Group Information

ATC CodeB02BD Blood coagulation factors
B02BD02 coagulation factor VIII


Licence Issued06/05/2011
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of Licence
Marketing Status


Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
« Back